Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Tocilizumab plus standard therapy for chronic antibody-mediated rejection after kidney transplant

Official title: Treatment of Chronic Active Antibody Mediated Rejection in Kidney Transplant Recipients With Tocilizumab ,IVIG, Plasmapheresis, Rituximab Versus IVIG, Plasmapheresis , Rituximab

Run by Shahid Beheshti University of Medical Sciences · NCT07006532 · Data updated 2026-11-12

This trial will try adding tocilizumab to standard treatment (plasmapheresis, IVIG, and rituximab) to see if it helps people with chronic active antibody-mediated rejection of a kidney transplant.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment50 (estimated)
SponsorShahid Beheshti University of Medical Sciences
Academic / other
Drugs / interventionsrituximab, Tocilizumab
Locations1 site (Tehran)
StatusRecruiting
StartedJanuary 1, 2025
Main results expectedJanuary 1, 2027
Study endsMay 1, 2027
Registry record updatedFebruary 11, 2026
Trial IDNCT07006532 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are kidney transplant recipients with biopsy-proven chronic active antibody-mediated rejection who have eGFR >25 mL/min, chronicity index <8, IFTA <40%, and are EBV IgG positive.

Probably not a fit

Patients with active or recurrent infections, abnormal liver function tests, low platelets (<100,000), recent or active malignancy, or very low kidney function (eGFR ≤25 mL/min) are unlikely to benefit or may be excluded.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label randomized trial tests whether adding the IL-6 blocker tocilizumab to standard care (plasmapheresis, IVIG, and rituximab) is safe and more effective for treating chronic active antibody-mediated rejection (CAMR) in kidney transplant recipients. Eligible participants meet biopsy and lab criteria (eGFR >25 mL/min, chronicity index <8, IFTA <40%, EBV IgG positive) and are randomized to receive standard therapy with or without tocilizumab. The study will track donor-specific antibody levels, graft function, and adverse events to determine safety and benefit. The trial is conducted at a single center in Tehran and is open-label.

Why it matters

Potential benefit: If successful, adding tocilizumab could lower donor-specific antibody levels and improve kidney graft survival in patients with CAMR.

How similar studies have gone: Some small case series and early trials of tocilizumab in antibody-mediated rejection have shown mixed signals for reducing donor-specific antibodies or stabilizing graft function, and other approaches like plasmapheresis, IVIG, rituximab, and bortezomib have produced inconsistent results in CAMR.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Signed written informed consent
2. eGFR\> 25 cc/min
3. Chronicity index \<8
4. IFTA\<40%
5. EBV IgG positive

Exclusion Criteria:

1. Active or recurrent infections
2. History of malignancy, unless in remission for more than 2 years with no relapse
3. abnormal liver function tests
4. Platelet \< 100,000

Where it's running

  • Nooshin Dalili
    Tehran, Iran
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.